Monoclonal Antibodies

Pharmacokinetics (PK)

Overview: Our pharmacokinetic analyses provide a detailed understanding of how your monoclonal antibodies are absorbed, distributed, metabolized, and excreted in the body. This critical information guides dosing strategies and ensures that the therapeutic reaches its target at effective concentrations.

Advanced Ligand Binding Assays: We employ ELISA and MSD-based immunoassays to accurately quantify antibody levels in serum or plasma over time.
Key Considerations: Our assays are finely tuned to detect full-length antibodies and any potential degradation products, ensuring reliable PK profiling.
Application Across Therapeutic Areas:
- Cancers: Optimizes antibody exposure within the tumor microenvironment for effective treatment.
- Autoimmune Diseases: Monitors distribution in inflammatory settings to maintain consistent therapeutic levels.
- Infectious Diseases: Confirms rapid bioavailability and sustained exposure necessary for pathogen neutralization.

Immunogenicity

Overview: Immunogenicity testing is crucial to ensure that monoclonal antibodies do not trigger unwanted immune responses that could reduce therapeutic efficacy or cause adverse reactions. Our rigorous testing protocols detect and quantify anti-drug antibodies (ADAs) early in development.

Sensitive Bridging Immunoassays: We utilize advanced ELISA-based methods to accurately detect ADAs against monoclonal antibodies.
Key Considerations: Our immunogenicity assays are designed to identify even low levels of ADAs, providing a comprehensive risk profile that supports regulatory requirements.
Application Across Therapeutic Areas:
- Cancers: Continuous dosing regimens require stringent monitoring to prevent neutralization.
- Autoimmune Diseases: Particularly important in patients with dysregulated immune systems to minimize additional immune activation.
- Infectious Diseases: Ensures that the antibody maintains its neutralizing capacity against pathogens.

Biomarkers and Pharmacodynamics

Overview: Our biomarker assays offer critical insights into the therapeutic impact of monoclonal antibodies. By monitoring key indicators, we can validate target engagement and correlate biological responses with clinical outcomes.

Advanced Ligand Binding & Multiplex Assays: These platforms measure essential biomarkers such as cytokines, soluble receptors, and tumor antigens.
Key Considerations: Our assays are optimized to capture subtle changes in biomarker levels that reflect the antibody’s mechanism of action.
Application Across Therapeutic Areas:
- Cancers: Tracks tumor markers and immune checkpoint proteins to monitor treatment efficacy.
- Autoimmune Diseases: Evaluates inflammatory mediators to gauge immune modulation.
- Infectious Diseases: Monitors both host and pathogen-derived biomarkers to validate effective pathogen neutralization.

CMC Bioanalytical

Overview: Our CMC bioanalytical services ensure that your monoclonal antibody therapeutics are manufactured with consistent quality. We verify that your product maintains structural integrity, purity, and functional activity throughout its lifecycle.

Structural Integrity & Purity Analysis: Using SDS-PAGE, capillary electrophoresis (CE-SDS), and glycan profiling, we confirm that the antibody is correctly assembled and free of contaminants.
Stability & Aggregation Studies: Techniques like Size-Exclusion Chromatography (SEC) and Dynamic Light Scattering (DLS) monitor the antibody for aggregation, degradation, or other quality shifts over time.
Potency Assays: Functional assays ensure that the monoclonal antibody retains its intended biological activity.
Key Considerations: Our tailored CMC approach addresses the challenges of antibody production, ensuring consistent quality from manufacturing through clinical application.
Application Across Therapeutic Areas:
- Cancers: Guarantees consistent performance, which is critical for effective cancer treatment.
- Autoimmune Diseases: Ensures reliable therapeutic action to modulate aberrant immune responses.
- Infectious Diseases: Maintains high quality standards that support effective pathogen neutralization.

Why Choose Our Analytical Platform?

Our expert team leverages state-of-the-art technologies and deep industry expertise to provide precise, actionable data. With our comprehensive analytical services, you can confidently advance your monoclonal antibody therapeutics from the lab to clinical application. Let us help you optimize dosing strategies, monitor therapeutic outcomes, and ensure the highest standards of product quality.